Glps
- 1. GOOD LABORATORY PRACTICES (GLPS) PREPARED BY : DHARMAJIT GOGOI DEPT. OF PHARMACOLOGY RIPANS, MIZORAM
- 2. GLP is an essential requirements of all modern testing facilities. GLP is an FDA regulation.
- 3. DEFINITION GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
- 4. HISTORY In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form, therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study. 3. Inadequate test systems.
- 5. In order to promote such principles International Conference on Harmonization (ICH), The Organization for Economic Cooperation and Development (OECD) have developed certain test guidelines and principles of GLP.
- 6. GLP provides an assurance to regulatory authorities that the data submitted are a true reflection of results obtained during the study and can, therefore, be relied upon when making risk/ safety assessment. GLP is a useful set of standards for any research laboratory wishing to standardise procedure and verify the reliability of the data produced.
- 7. GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. Quality Assurance Programme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performance of The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.
- 8. COMPONENTS OF A NON CLINICAL GLP STUDY Nonclinical laboratory study means any in vivo or vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine whether a test article has any potential utility or to determine physical or chemical characterization of a test article. Test articles means any food additives, colour additives, drugs, biological products, electronic products, medical devices for human use.
- 9. STANDARD OPERATING PROCEDURES(SOPS) Written procedures for a laboratories program. They define how to carry out protocol specified activities. Most often written in a chronological listing of action steps. They are written to explain how the procedures are suppose to work.
- 10. Routine inspection, cleaning, maintenance, testing and calibration. Actions to be taken in response to equipment failure. Keeping records, reporting, storage, mixing, and retrieval of data. Definition of raw data. Analytical methods.
- 11. STUDY DIRECTOR A scientist or other professional of appropriate education, training and experience, or combination there of, shall be identified as a study director. o He has responsibility- Technical conduct of the study, Interpretation, Analysis, Documentation, Reporting of the results, Represent the single point of the study conduct
- 12. PERSONNEL A person responsible for a non clinical laboratory study shall have education, training, experience to enable that individual to perform the assigned functions. Each testing facility shall maintain a current summery of training and experience and job description for each individual. Health records for each individual. appropriate clothing during in the laboratory.